Five ways to make your regulatory submission run more smoothly

As your global partner for regulatory affairs solutions, we at Dora Wirth (Languages) Ltd would like to share some tips to help you prepare your EU regulatory submission.

 

1. Beat the clock.

Your team will have taken great care to produce a high-quality English draft for approval/submission, so please make sure you allow time for us to provide you with 24 translations of equal quality.

Occasionally DWL will be working right up until your requested deadline, balancing your requirements with those of translators, reviewers and National Competent Authorities (NCAs). Allow us as much time as possible, and read on for more tips that will save you time and money.

2. Document versions: be a control freak.

We have an efficient system in place for reception, processing, delivery and archiving, so it can quickly become apparent if steps have been missed, or if changes have not been recorded within the English source file tracking.

If you regularly work with multiple service providers, don’t assume that we hold the latest version of your reference documents.

3. Give it to us straight.

Our team of professional linguists will adhere very closely to your instructions. The time it takes to administer a change of instructions must be multiplied by the number of languages involved, so take the time to give our project managers the full picture. This includes background information (previous product history, regulatory procedure), QRD versions, tracking IDs, linguistic preferences and reference material. Do you have a point of contact for translator queries?

Aim to communicate your requirements clearly, and be on hand to respond to any translator queries along the way.

4. We like your style.

There are many client preferences when it comes to approaching regulatory submissions at the translation stage. Express up front exactly how we can align with your internal procedures including file naming conventions, liaising with national competent authorities/MS (Member State) reviewers and QRD Form 2 feedback. We will be happy to comply.

Make sure you specify which QRD template we should follow, which file formats you require (e.g. clean/annotated .doc files, bookmarked pdf files), as well as any other information which will help our team tailor the assignment to your needs.

5. Tell us what you really think.

We are constantly seeking to improve our service, and we rely on your feedback to know whether you are truly satisfied.

 

Please get in touch to discuss your requirements, and to find out how we can make your submission process easier.